CTRI Number |
CTRI/2017/10/010136 [Registered on: 18/10/2017] Trial Registered Retrospectively |
Last Modified On: |
16/10/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Microsurgical management Of Gingival Recession Defects With Autologous Platelet Rich Fibrin (PRF) And Autogenous Connective Tissue Graft (CTG) In Conjunction With Coronally Advanced Flap: A Comparative Clinical Study |
Scientific Title of Study
|
Treatment Of Gingival Recession Defects With Autologous Platelet Rich Fibrin (PRF) And Autogenous Connective Tissue Graft (CTG) In Conjunction With Coronally Advanced Flap Using Microsurgical Technique: A Comparative Clinical Study |
Trial Acronym |
PRF&CTG |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Archana Kumar |
Designation |
Postgraduate Student |
Affiliation |
Saraswati Dental College, Lucknow |
Address |
Department of Periodontology,
Saraswati Dental College,
233, Tiwariganj, Faizabad Road, Chinhat, Lucknow
Lucknow UTTAR PRADESH 226028 India |
Phone |
|
Fax |
|
Email |
archanakumar.archana@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vivek Kumar Bains |
Designation |
Professor |
Affiliation |
Saraswati Dental College, Lucknow |
Address |
Department of Periodontology,
Saraswati Dental College,
233, Tiwariganj, Faizabad Road, Chinhat, Lucknow
Lucknow UTTAR PRADESH 226028 India |
Phone |
9935023439 |
Fax |
|
Email |
doc_vivek76@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Vivek Kumar Bains |
Designation |
Professor |
Affiliation |
Saraswati Dental College, Lucknow |
Address |
Department of Periodontology,
Saraswati Dental College,
233, Tiwariganj, Faizabad Road, Chinhat, Lucknow
Lucknow UTTAR PRADESH 226028 India |
Phone |
9935023439 |
Fax |
|
Email |
doc_vivek76@yahoo.co.in |
|
Source of Monetary or Material Support
|
Self Funded
Infrastructural to carry out study was provided by Saraswati Dental Colege, Lucknow |
|
Primary Sponsor
|
Name |
Saraswati Dental College Lucknow |
Address |
Saraswati Dental College,
233, Tiwariganj, Faizabad Road, Chinhat, Lucknow |
Type of Sponsor |
Other [Infrastructural support by Institution] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Vivek Kmuar Bains |
Sraswati Dental College, Lucknow |
Department of Peridontology, Saraswati Dental College, 233, Tiwariganj, Faizabad Road, Chinhat, Lucknow Lucknow UTTAR PRADESH |
9935023439
doc_vivek76@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Insitutional Human Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Dental patients having Class I and Class II gingival resession in uppr anterior teeth, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Coronally advanced flap |
Treatment of gingival recession using coronally advanced flap procedure |
Comparator Agent |
Platelet rich fibrin,
Connective tssue graft,
CAF alone (Control) |
Gingival recession sites were treated with Coronally advanced flap with platlet rich fibrin,
connective tissue graft, or alone |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Both |
Details |
Patients (1) having at least one tooth in maxillary anterior teeth region with Millers Class I or Class II labial gingival recession defect; (2) in good general health (ASA-I) with no contraindications for periodontal surgery; (3) not using antibiotics, corticosteroids, chemotherapeutics, immunomodulators, or others that modify the results of periodontal therapy during the last six months; (4) selected teeth must be free of endodontic treatment, buccal or interproximal restoration; (5) who have not undergone any periodontal treatment in the preceding six months of initial examination. |
|
ExclusionCriteria |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Probing pocket depth,
Clinical attachment level,
Horizontal gingival recession,
Vertical gingival recession,
Hypersensitivity score,
Patient esthetic score,
Patient comfort score,
at 3 months and 6 months |
At 3 months and 6 months post-intervention |
|
Secondary Outcome
|
Outcome |
TimePoints |
Gingival thickness
Patient esthetic score,
hypersenstivity score at 10 days, 3 months and 6 months |
3 months and 6 months |
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
19/12/2013 |
Date of Study Completion (India) |
25/11/2015 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
The paper is published.
DOI: 10.4103/ccd.ccd_70_17 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Purpose: To evaluate autologous Platelet Rich Fibrin (PRF) and autogenous Connective Tissue Graft (CTG) in gingival recession defects in conjunction with coronally advanced flap (CAF) using microsurgical technique. Materials and Methods: Forty-five class I and II recession defects were randomly equally (n=15) divided into three groups: Group I sites treated with CAF with PRF; Group II sites treated with CAF with CTG and Group III sites treated with CAF alone using microsurgical approach in 36 patients. Parameters recorded were vertical (VGR) and horizontal gingival recession (HGR), % Complete root coverage (CRC), Patient comfort score (PCS), Patient esthetic score (PES) and Hypersensitivity score (HS) at 10 days, 3 months and 6 months. Results: CAF surgery alone and in combination with PRF or CTG, are effective procedures to cover denuded roots with mean VGR values of 1.26±0.70 mm (74.4%), 1.26±0.59 mm (58%) and 1.06±0.79 mm (53.3%) for Group I, II and III. In terms of complete root coverage (CRC) achieved at 6 months, results showed that 100% CRC was obtained in 60 % sites of Group I, 20 % sites of Group II and 27% in Group III. Patient response and acceptance for surgical treatment modality in terms of PCS and PES was highest for Group I (PRF and CAF) followed by Group III, and Group II; and there was decrease in hypersensitivity score (HS) for Group I (PRF and CAF) while no significant changes in HS scores were observed for Group II and Group III. At the end of six months follow-up there was significant increase in gingival thickness measurements using transgingival probing in Group II, whereas non-significant changes were observed in Group 1and Group III. Conclusions: Long term multicentric randomized controlled clinical study may be necessary to evaluate the clinical outcome for autologous PRF in comparison to CTG and CAF alone. |